LuciRepo

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciRepo safely and effectively. See full prescribing information for LuciRepo.

 

INDICATIONS AND USAGE

LuciRepo is a kinase inhibitor indicated for the treatment of adult patients with locally

advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). 

 

DOSAGE AND ADMINISTRATION

• Select patients for the treatment of locally advanced or metastatic NSCLC based on the presence of ROS1 rearrangement(s) in tumor specimens.

• Recommended Dosage: 160 mg orally once daily for 14 days, then increase to 160 mg twice daily, with or without food. 

 

DOSAGE FORMS AND STRENGTHS

Capsules: 40 mg×60 capsules

 

CONTRAINDICATIONS

None.

 

WARNINGS AND PRECAUTIONS

• Central Nervous System (CNS) Effects: Can cause CNS adverse reactions including dizziness, ataxia, and cognitive impairment. Withhold and then resume at same or reduced dose upon improvement, or permanently discontinue LuciRepo based on severity.

• Interstitial Lung Disease (ILD)/Pneumonitis: Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.

• Hepatotoxicity: Monitor liver function tests every 2 weeks during the first month of treatment, and as clinically indicated thereafter. Based on severity, withhold and then resume at same or reduced dose, or permanently discontinue.

• Myalgia with Creatine Phosphokinase (CPK) Elevation: Monitor serum CPK levels during treatment in patients reporting unexplained muscle pain, tenderness, or weakness. Based on severity, withhold and resume at same or reduced dose upon improvement.

• Hyperuricemia: Monitor serum uric acid levels prior to initiating and periodically during treatment. Initiate treatment with urate-lowering medications as clinically indicated. Withhold and resume at same or reduced dose, or permanently discontinue based on severity.

• Skeletal Fractures: Promptly evaluate patients with signs or symptoms (e.g., pain, changes in mobility, deformity) of fractures.

• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use an effective non-hormonal method of contraception. 

 

ADVERSE REACTIONS

The most common adverse reactions (≥20%) were dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, ataxia, fatigue, cognitive disorders, and muscular weakness. 

 

DRUG INTERACTIONS

• Strong and Moderate CYP3A Inhibitors: Avoid concomitant use.

• P-gp inhibitors: Avoid concomitant use.

• Strong and Moderate CYP3A Inducers: Avoid concomitant use.

• Certain CYP3A Substrates: Avoid concomitant use with CYP3A substrates, where minimal concentration changes can cause reduced efficacy.

• Hormonal contraceptives: Avoid concomitant use. 

 

USE IN SPECIFIC POPULATIONS

• Lactation: Advise not to breastfeed. 

 

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.